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Norethindrone
Overview
What is HEATHER?
Each pale yellow HEATHER tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone USP daily, and the inactive ingredients include corn starch, lactose monohydrate, magnesium stearate, povidone, talc, D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminium lake.
The chemical name for norethindrone USP is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows:
Norethindrone USP
Therapeutic class = oral contraceptive
What does HEATHER look like?
What are the available doses of HEATHER?
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What should I talk to my health care provider before I take HEATHER?
Sorry No records found
How should I use HEATHER?
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
To achieve maximum contraceptive effectiveness, HEATHER must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See for detailed instructions.
What interacts with HEATHER?
- Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:
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What are the warnings of HEATHER?
In a few patients on bromocriptine mesylate, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported. To ensure recognition of retroperitoneal fibrosis at an early reversible stage it is recommended that its manifestations (e.g., back pain, edema of the lower limbs, impaired kidney function) should be watched in this category of patients. Bromocriptine mesylate medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
HEATHER does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.
The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
1. Ectopic pregnancy
The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.
2. Delayed follicular atresia/Ovarian cysts
If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.
3. Irregular genital bleeding
Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.
4. Carcinoma of the breast and reproductive organs
Some epidemiologic studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increase the risk. Women with breast cancer should not use oral contraceptives because the role of female hormone in breast cancer has not been fully determined.
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.
5. Hepatic neoplasia.
Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies from Britain and the U.S. have shown as increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.
What are the precautions of HEATHER?
1. General
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
2. Physical examination and follow-up
It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.
3. Carbohydrate and lipid metabolism
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin, but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is no effect on total cholesterol, HDL, LDL, or VLDL.
4. Drug Interactions
Change in contraceptive effectiveness associated with co-administration of other products:
a. Anti-infective agents and anticonvulsants
Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.
b. Anti-HIV protease inhibitors
Several of the anti-HIV protease inhibitors have been studied with co-administration of oral contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of OC products may be affected with the co-administration of anti-HIV protease inhibitors. Health care providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
c. Herbal products
Herbal products containing St. John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
5. Interactions with laboratory tests
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The following endocrine tests may be affected by progestin-only oral contraceptive use
6. Carcinogenesis
See section
7. Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
8. Nursing mothers
Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1-6% of the levels of maternal plasma. However, isolated post-market cases of decreased milk production have been reported in POPs. Very rarely, adverse effects in the infant/child have been reported, including jaundice.
9. Fertility following discontinuation
The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.
10. Headache/Migraine
If you have a headache or a worsening migraine headache with a new pattern that is recurrent, persistent, or severe, this requires discontinuation of oral contraceptives and evaluation of the cause.
11. Gastrointestinal
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.
12. Pediatric use
Safety and efficacy of HEATHER has been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
Information for the Patient
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The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives
What are the side effects of HEATHER?
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What should I look out for while using HEATHER?
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
HEATHER does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.
The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
What might happen if I take too much HEATHER?
There have been no reports of serious ill effects from overdosage, including ingestion by children.
How should I store and handle HEATHER?
Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].HEATHER (Norethindrone tablets USP, 0.35 mg) are available in 28-tablet dispensers as pale yellow round, flat faced beveled edged, uncoated tablets with ‘303’ debossed on one side and ‘G’ on the other side (NDC 68462-303-29).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
HEATHER progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
Non-Clinical Toxicology
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
HEATHER does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.
The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
Change in contraceptive effectiveness associated with co-administration of other products:
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
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Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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